Reducing heart disease risk in 12–15-year-olds with severe obesity
Official title: Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
Run by University of Kentucky · NCT06967389 · Data updated 2026-11-12
This will try semaglutide in 12–15-year-olds with class 2–3 obesity to see if it changes weight, heart-related risk markers, body composition, and fitness over about a year.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT06967389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 12–15-year-olds with class 2 or 3 obesity who are patients at the University of Kentucky Pediatric High BMI Clinic and meet clinical criteria to start semaglutide without exclusionary conditions.
✕Probably not a fit
Patients currently taking other anti-obesity or certain antihypertensive medications, with active organ disease, pregnancy, MRI incompatibility, or genetic syndromes associated with obesity are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study gives semaglutide to about 50 adolescents (ages 12–15) with class 2 or 3 obesity seen at the University of Kentucky Pediatric High BMI Clinic and follows them for approximately 12 months. Participants will be titrated to a maintenance semaglutide dose and undergo baseline and ~12-month follow-up assessments including cardiac MRI or echocardiography, body composition testing, exercise/fitness testing, and blood and urine sampling. There is no randomization or placebo arm; all enrolled participants receive the drug and biologic samples will be stored de-identified indefinitely. The analysis will track how weight loss, BMI, body composition, heart structure/function, and fitness change together and whether sex or other factors influence outcomes.
Why it matters
Potential benefit: If successful, it could show semaglutide reduces BMI and improves heart structure, function, and fitness in severely obese adolescents, lowering future cardiovascular risk.
How similar studies have gone: Large adult trials have shown substantial weight loss with semaglutide, and emerging pediatric reports are promising though controlled pediatric outcome data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient seen at University of Kentucky Pediatric High BMI Clinic * Diagnosis of Obesity Class 2 or 3 * Meeting the clinical criteria for the medical intervention with semaglutide for weight loss Exclusion Criteria: * Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine/Topiramate), Liraglutide, Semaglutide, and Setmelanotide * Any current prescribed anti-hypertensive medications * Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease). * Any active infections at enrollment. * Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical). * Any limitations that would make exercise testing not possible. * Any congenital abnormality or genetic syndrome known to be associated with obesity * Pregnancy * Inability to receive an MRI * Personal or family history of medullary thyroid carcinoma (per product insert) * Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)
Where it's running
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University of Kentucky
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Margaret Murphy, RD PhD — University of Kentucky
- Study coordinator: Margaret Murphy, RD PhD
- Email: maggie.murphy@uky.edu
- Phone: 859-323-2969
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.